Trial Examines Efficacy Of Merck's Antiretroviral Raltegravir

Armen Hareyan's picture

The TucsonCitizen onMonday examined a worldwide trial of Merck's antiretroviral drug raltegravirbased at the El Rio Community Health Center in Arizona. The trial, which is sponsored byMerck, includes participants who have become resistant to other treatments. Accordingto the Citizen, the study includes 40 different clinics in the U.S., as well as clinics in South America and Europe. Each clinic participating in the trial has sixparticipants in the study, the Citizen reports (Rowley, TucsonCitizen, 3/24).

FDA in October 2007 approved raltegravir for useby HIV-positive people who have not responded to other treatments. Raltegravirworks by blocking an HIV enzyme called integrase. Integrase is one of the threeenzymes necessary for HIV to replicate in the body, and integrase inhibitorsstop HIV from inserting its genes into uninfected DNA. Raltegravir is soldunder the brand name Isentress (Kaiser DailyHIV/AIDS Report, 10/15/07).


Fritz Bredeek -- principle investigator for the study in Arizona and a physician at the El Rio HIVClinic -- said that the study participants "were the least treatable"when they enrolled. Kevin Carmichael, head of the El Rio HIV Clinic, said thathe saw HIV-positive people "who were failing therapy." He added thatthey were "dying" and that raltegravir "saved their lives."Bredeek said that when FDA reviews the results of the study at the 48-weekmark, he believes the drug will be approved for use by all people living withHIV/AIDS.

Robin Isaacs, Merck's director of clinical research, said that an unrelatedstudy is under way to examine the effects of raltegravir among people who havenever taken antiretrovirals. Those results will be presented to FDA at the endof the year, the Citizen reports (Tucson Citizen,3/24).

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